Feasibility BFRT Geriatric Stroke Patients
- Conditions
- Stroke
- Interventions
- Other: Blood flow restriction trainingOther: Opinions
- Registration Number
- NCT06398041
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
The focus of this interventional study is to assess the feasibility of blood flow restriction training (BFRT) in a geriatric stroke population. Patients will undergo a 4-week program of BFRT additionally to our standard physiotherapy, conducted twice weekly by experienced physiotherapists.
The main goal of the study is to assess its feasibility concerning the safety and tolerance of BFRT from a patients and therapists scope. Furthermore, the investigators want to establish the proportion of eligible individuals \& their willingness to undergo BFRT, as well as the time investment.
The feasibility of an effectiveness study and potential sample size will be evaluated aside.
- Detailed Description
Stroke is often linked to a loss in muscle strength and a decline in functioning during daily life. In the past, several studies have focused on the effects of resistance training on muscle strength in order to restore patients functioning in daily life. For optimal improvements in muscle strength, the use of high loads with few repetitions per set have been recommended, even within the geriatric population. However, the use of high load exercises in a geriatric population can often be challenging, particularly in patients who have suffered a stroke.
To counter this, blood flow restriction training (BFRT) might give some opportunities. BFRT is a relatively new technique for strength training using a cuff to compromise blood flow in combination with low loads. It is a Japanese technique from origin also known as KAATSU and has been proven to be effective in several populations, including a geriatric population.
During this study, patients will undergo 8 sessions of BFRT given by experienced physiotherapists, twice a week during a 4-week program additionally to standard physiotherapy program: the Geriatric Activation Program Pellenberg (GAPP). Each patient will undergo 1 or 2 specific predetermined exercises for the upper or lower limb, based on the individual goals.
The main goal of the study is to assess its feasibility concerning the safety and tolerance of BFRT from a patients and therapists scope. Furthermore, the investigators want to establish the proportion of eligible individuals \& their willingness to undergo BFRT, as well as the time investment.
The feasibility of an effectiveness study and potential sample size will be evaluated aside.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 16
Not provided
- Skin lesions located at the site of the cuff
- Cognitive impairment making it impossible to understand the exercises
- Severe comorbidities: (Deep Venous Thrombosis; Open wounds or infected wounds; Dialysis; Cancer; Severe High Blood pressure)
B. Healthcare workers:
Inclusion Criteria
- being physiotherapist involved in the practical application of BFRT
- signed informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Patients Blood flow restriction training Patients will undergo 8x a BFRT session and will be asked about their feelings and thoughts using a VAS an 7 points Likert Scale Patients Opinions Patients will undergo 8x a BFRT session and will be asked about their feelings and thoughts using a VAS an 7 points Likert Scale Physiotherapists Opinions Physiotherapists involved in the practical application of BFRT will be asked about their thoughts using a 7 point Likert Scale
- Primary Outcome Measures
Name Time Method Feasibility assessed by the physiotherapist 1 year Feasibility assessed by the physiotherapist using a 7point Likert Scale for an agreement with several statements and will include options: strongly disagree, disagree, somewhat disagree, either agree or disagree, somewhat agree, and agree
Proportion of eligible individuals and their willingness to undergo BFRT 1 year Number of available patients on the ward and number of eligible patients and number of patients who participate
Prevalence and types of Adverse events 1 year During the entire time frame of the study, all adverse events will be collected and sorted into different categories. Furthermore, the prevalence of this types will be calculated
Rate of attended sessions over the total number of sessions planned During a time frame of 1 year, this will be calculated during 4weeks/subject attended sessions over the total number of sessions planned
Time investment 4 weeks/subject the time needed to execute the exercises will be divided by the total time (time to prepare the patient, calibrate the cuff pressure and execute the exercises)
Feasibility assessed by the patients During a time frame of 1 year, this will be calculated during 4weeks/subject Feasibility assessed by the patients using a 7point Likert Scale for an agreement with several statements and will include options: strongly disagree, disagree, somewhat disagree, either agree or disagree, somewhat agree, and agree
Visual Analog Scale for feelings of perceived pain, effort, safety and comfort During a time frame of 1 year, each subject will be asked to complete a VAS-scale after every trainingssession (8x/subject over a period of 4 weeks) Feelings of perceived pain, effort, safety and comfort will be scored after every trainingssession with a visual analog scale
- Secondary Outcome Measures
Name Time Method Active ROM against gravity During a time frame of 1 year, each subject will tested at baseline and the day following the last training session (to counteract fatigue) (2 times over 5 weeks/subject) the active ROM measured with goniometer, with higher scores mean a better outcome
Muscle Strength 1 During a time frame of 1 year, each subject will tested at baseline and the day following the last training session (to counteract fatigue) (2 times over 5 weeks/subject) The Medical Research Council (MRC) Scale for Muscle Strength, scores ranging from 0 to 5, with higher scores mean a better outcome
Muscle Strength 2 During a time frame of 1 year, each subject will tested at baseline and the day following the last training session (to counteract fatigue) (2 times over 5 weeks/subject) Muscle strength using a handheld dynamometer (MicroFet2), with higher scores mean a better outcome
Functional balance During a time frame of 1 year, each subject will tested at baseline and the day following the last training session (to counteract fatigue) (2 times over 5 weeks/subject) Berg Balance Scale (BBS), scores ranging from 0 to 56, with higher scores mean a better outcome
Walking speed During a time frame of 1 year, each subject will tested at baseline and the day following the last training session (to counteract fatigue) (2 times over 5 weeks/subject) 10 Meter walking test (10MWT)
Trial Locations
- Locations (1)
Universitaire Ziekenhuizen Leuven, campus Pellenberg
🇧🇪Pellenberg, Belgium